PUBLIC COMMENT-2022-61 HS Statewide STEMI System

COMMENTOR AND ORGANIZATION

PUBLIC HEARING

OR WRITTEN

RULE NUMBER

COMMENT

DHHS RESPONSE

Dr. Abed Asfour, MD, Corewell Health

East and West

Public Hearing

General Comments

I’m going to address a set of the rural hospitals in

The white paper A Statewide System of Care For Time

regarding accreditation the State of Michigan, as well as I’m going to address, Sensitive Emergencies: The Integration of Stroke and

to some degree, but I will leave it to some of my STEMI Care into the Regional Trauma System, and the

colleagues, the open-heart surgery hospitals and the admistative rules drafts were written by a group of

limitations and the advantages of looking into this stakeholders and professional subject matter experts

rule in different prospect. Requiring accreditation including representatives from rural regions of the

may seem reasonable on paper, but it could be like state. Systems of care take into consideration the

chasing some (inaudible) in the rural hospitals. The geogrpahical differences and resource allocation

costs, the complexities, the diversion of resources are across the state, and work to "incorporate a variety of

very import-, very critical to these places.

disparate healtcare components into a formal

structure that is established, supported and

supervised within statutes, administrative rules and

policy."Primary emergent treatment for an ST-

Elevation Myocardial Infarction is to have a

Percutaneous Coronary Intervention (PCI) in 120

minutes, failing that, IV therapuetics (clot buster)

within 12 hours of after symptom onset (If

appropriate). SCAI Expert Consensus Statement on PCI

without On-Site Surgical Back-up reported a <0.1%

rate of emergent bypass surgery post PCI. Open Heart

Surgery as treatment for a STEMI is an important

The Department has been charged with integration of

the STEMI System of Care into the existing trauma

Eric Jakovac, Director of Heart and

Vascular Services at Corewell Health

and Beaumont University Hospita

Public Hearing

General Comments

regarding accreditation accreditation to our cath labs and chest pain

You know, we think that adding an additional

facilities, especially those that have these very robust system. Part of that charge is developing a process

programs and CV surgery and open-heart surgery

back up, it seems a little redundant. You know, we

for designation of facilites. The stakeholders and

professional subject matter experts that helped to

have been working very hard to continue to improve draft these rules agreed that the process outlined in A

our patient outcomes, with our quality, we continue Statewide System of Care For Time Sensitive

to do so. And we don’t necessarily think or see

Emergencies: The Integration of Stroke and STEMI Care

potentially the value of accreditation, on top of what into the Regional Trauma System including verfication

we are already doing.

of the level of care provided at each facility by written

proof of certification or accreditation through a

professional-nationally recognized organization

would help to establish a minimum standard of care

in the state. According to the American Heart

Association System of Care for ST-Segment Elevation

Myocardial Infarction: A Policy Statement from the

AHA "STEMI referring hospitals and STEMI receiving

centers have specific roles in a STEMI system of care,

and each should be as prepared as possible to

collaboratively perform evidence-based, lifesaving

treatment." Accreditation is the process that identifies

and establishes the roles and responsibilites. Thus

ensuring that all partners, stakeholders and the

public understand quickly what services each facility

is capable of, limiting an important barrier to care

delivery in a very time dependent emergency. STEMI

SOC requires a categorization of resources

General Comments

regarding accreditation comes to pay, when it comes to time, when it comes to doctor that they had a heart attack. Accredidation

resources to not only get accreditation, but to provides enhanced uniformity in care, opportunities

But there’s also additional concerns we have when it In 2021 4.3% of Michigan residents were told by their

maintain that accreditation over the course of time. to stregthen protocols, procedures, ensures patients

So, we’ve been all aware that there is a financial cost are transferred to facilities that have the appropriate

that would, we would incur choosing a third-party

services and that data is collected to drive decision

accreditation. But there’s also the cost of who’s going making, identify gaps and subsequent methods to

to continue to manage those data points that we need address. STEMI Systems of Care have been in

to, who’s going to continue to keep things rolling if

we’re chucking everything, sending everything

existence for years (Europe, Australia, US, India,

Indodesia, Egypt, and others) as compelling evidence

inappropriately and doing all that, as well as the time points to decrease in mortality when quality care is

Dr Samir Dabbous, MD, Interventional Public Hearing

Cardiologist, Corewell Health East

General Comments

We really don’t need another body that tells us

Accreditation is an objective evaluation process that

can help organizations measure, assess and improve

regarding accreditation exactly what we’re supposed to do, whether how,

whether we should be accredited or not because we performance. White Paper: A systematic approach to

have been doing this for quite a while. And instead of STEMI care ensures that STEMI patients are integrated

spending more money on accreditation and have FTEs into a system of regional healthcare providers who are

to look at these metrics and report them to the ACC or well trained and have the resources to provide optimal

whoever. I would rather make, focus more on

care.... It also ensures that all STEMI patients are part of

staffing, patients that we’re having major issues with a system of coordinated care based on standardized

right now, whether it is the nursing care or critical

care area.

triage criteria and regional destination protocols. R

330.205 Rule 5 A healthcare facility may participate

in the system to the extent or level that it commits the

resources necessary for the appropriate management

of STEMI patients.

Colin McDonough, Michigan

Government Relations Director for the

American Heart Association

Public Hearing

R 330.201 (See DHHS

response)

In R 330.201, the American Heart Association

recommends updating the definitions of

“accreditation” and “certification” and clarify and

avoid confusion. For the definition of “disciplinary

action”, we suggest including EMS agencies as they

may also fail to comply with the Code

DHHS opposes this recommendation. It appears that

the commentor may have inadvertently used a

previous draft of the rule set. There is no definition of

accreditation. The definition of accreditation was

removed because it is not used in the body of the

document. Stroke programs receive certification from

national professional review organizations.

R 330.203

For R 330.203, it is recommended that the definition The published definition was developed by the White

of “PCI” align with the Michigan Department of Health Paper Expert Writing Group. Definitions must align

and Human Services certificate of need review

standards for cardiac catheterization services.

Currently, the term does not include the inter-

and not contravene already adopted language. The

defintion of "PCI" was agreed upon by the

stakeholders and professional subject matter experts

coronary administration of drugs, FFR, or IVUS where from the administrative rules work group.

these are the only procedures performed.

Public Hearing

R 330.201

In R 330.201, the American Heart Association

recommends updating the definitions of

“accreditation” and “certification” and clarify and

avoid confusion. For the definition of “disciplinary

action”, we suggest including EMS agencies as they

may also fail to comply with the Code

DHHS opposes this recommendation.The department

is charged with integration of the Stroke System of

Care into the existing Trauma System. The definition

of certification was agreed upon by the administrative

rules work group made up of stakeholders and

professional subject matter experts across the state

of Michigan. Integration requires consistency across

the service lines.

Certification provides verification of resources that

the departments uses to designate facilities based

upon the level that the hospital is certified as.

Public Hearing

R 330.201

R 330.253

In R 330.201, the American Heart Association

recommends updating the definitions of

“accreditation” and “certification” and clarify and

avoid confusion. For the definition of “disciplinary

action”, we suggest including EMS agencies as they

may also fail to comply with the Code

The regional STEMI advisory council and the

statewide STEMI care advisory subcommittee both

pose ambiguity around their membership. For

instance, is the American Heart Association

considered a consumer under the regional STEMI

advisory council? For both the council and

DHHS opposes this suggestion. EMS regulations are

addressed in the EMS rule set. Disciplinary action for

EMS agencies is fully described in Mich Admin Code R

325.22126.

The Regional Advisory Council membership is

modeled on Mich Admin Code R 325.127. Rule 3(h)

which supports the intended system integration by

including broad stakeholder titles: MCA personnel,

emergency medical services (EMS) personnel, life

support agency representatives, health care facility

subcommittee, we recommend a definition inclusive representatives, physician, nurses and consumers to

of expertise in this specific field, such as

professional organization with expertise in STEMI

systems of care.

avoid being over prescriptive and inadvertently

exclusive of an important partner/stakeholder. Policy

will further refine roles with stakeholder input as

described in A Statewide System of Care for Time

Sensitive Emergencies: The Integration of Stroke and

STEMI Care into the Regional Trauma System. A

Consumer will be a Michigan resident who has

experience with the system who can provide

perspective and input on system impacts and how to

improve. A national organization would not be

considered a consumer. It is expected that the content

experts on the advisory council and committee are

members of and/or participate with national

organizations and can reflect the current position of

these bodies as it relates to the state.

Public Hearing

R 330.253(1)(p)

In section (1)(p), we suggest moving “education”, “risk The definition of STEMI care was drafted by stake

reduction”, and “sub-acute”. These seem to be beyond holders and professional subject matter experts to

the scope of the administrative Code and capabilities define the care that is provided by the facilities.

of the Bureau

These are programmatic standards that are used to

measure the care provided by accredited and certified

STEMI facilities.

R 330.253(1)(l)

R 330.253(1)(m)

Additionally, the Association requests the removal of The definition was agreed upon by the stakeholders

the word “comprehensive” in the definition of

“statewide STEMI system of care”.

and professional subject matter experts that drafted

these administrative rules.

Public Hearing

In totality, the American Heart Association believes

STEMI should be replaced with “heart attack”. The

term STEMI is a medical term not often used and

understood by the public.

The intention of the system is to address the time

sensitive identification and treatment of ST Elevation

Myocardial Infarction.There is an important

distinction between the term heart attack and STEMI. A

heart attack is a term that can be used to describe the

outcome of a partially blocked coronary artery, an

artery spasm, or a coronary artery tear. A STEMI is a

specific kind of heart attack due to a complete

blockage of a coronary atery that is treated in a

specific, time sensitive manner. STEMI is a specific

high-risk type of heart attack that requires prompt

recognitiom amd emergent treatment.

Public Hearing

General comment.

R 330.254(1)(a)

In that vein, we believe the definition of “STEMI

The White Paper Expert Writing Group formalized the

referral facility” should include various other words definitions. These were initially introduced in 2011

like heart attack, chest pain center, and other relevant when the SOC discussion began. The defintion was

terms that hospitals may use to advertise themselves aggreed upon by the stakeholders and professional

as providing STEMI or heart attack care.

subject matter experts that helped to draft these rules.

R 330.204(1)(a) should remove the term “all-

DHHS opposes this recommendation. Voluntary all-

inclusive”. In theory, all-inclusive indicates primary inclusive systems are the foundational model of the

prevention through rehabilitation which may be

beyond the scope and capabilities of the Bureau.

Trauma regulations use all inclusive, but does this

really include sub-acute and rehabilitation?

existing trauma system as well as the developing

stroke system. Systems function best if all

components participate to the best of their available

resources. The system is inclusive and voluntary.

Public Hearing

R 330.254(1)(e)

The Association also believes (1)(e) should be

modified because Michigan may have its own

The language "nationally recognized professional

certifying and accrediting organization" was aggreed

certification accreditation based on the definition of upon by the stakeholders and professional subject

verification within the rules. Trauma regulations

specifically reference the American College of

Surgeons, and the American Heart Association

strongly recommends adoption of the joint

commission American Heart Association. At

minimum, we suggest listing both the joint

matter experts that helped to draft this rule set. The

group recognized that while the Trauma System has

one accrediting organization, there are several

organizations that certify and accredit for cardiac

care. This language will allow for the department and

the advisory body to review and update the list of

commission and the American College of Cardiology. apporved organizations though policy and procedure.

The department designates STEMI refering hospitals

and STEMI receiving facilities based on verification of

Public Hearing

R 330.254(1)(f)

General

AHA believes the verbiage surrounding (1)(f) could

lead to confusion and should be revisited.

The state has an established designation process for

the Trauma System and intends to mirror this for the

STEMI System.

Further, when developing a statewide STEMI data

As noted in the AHA paper cited above "Among the

collection system, we believe MDHHS should follow barriers remaining is establishing the ideal STEMI

the trauma regulations which read, quote: The system of are are local and regional challenges,

Department shall do all of the following: a. Adopt the resource and financial issues and no single US STEMI

national trauma data standard elements in

definitions as a minimum set of elements for data

collection, with the addition of elements as

recommended by the STAC, unquote.

registry." The White Paper recommendation is that a

statewide STEMI data registry will be established by the

Department, including the establishment of a minimum

data set, data dictionary, and the data upload and

data verification process. The submission of data to the

STEMI registry will be phased in in order to support the

efficient and orderly establishment of designated STEMI

facilities.

General

a. Adopt the national trauma data standard elements As noted in the AHA paper cited above "Among the

in definitions as a minimum set of elements for data barriers remaining is establishing the ideal STEMI

collection, with the addition of elements as

recommended by the STAC, unquote.

system of are are local and regional challenges,

resource and financial issues and no single US STEMI

registry." The White Paper recommendation is that a

statewide STEMI data registry will be established by the

Department, including the establishment of a minimum

data set, data dictionary, and the data upload and

data verification process. The submission of data to the

STEMI registry will be phased in in order to support the

efficient and orderly establishment of designated STEMI

facilities.

Public Hearing

General

In these rules, the Association would like to see an

A common set of data elements and corresponding

exportation to get with the guidelines coronary artery data dictionary that interfaces with all three systems

disease.

and EMS patient care records and allows for file

transfer to other databases is outlined in A Statewide

System of Care for Time Sensitive Emergencies The

Integration of Stroke and STEMI Care into the Regional

Trauma System (pg16) and included in the current

Request for Proposal for a contract with a company

who can provide this.

Public Hearing

General

In disciplinary situations, the Department should

include EMS, as well as the STEMI center or facility.

DHHS opposes this suggestion. EMS regulations are

addressed in the EMS rule set. Disciplinary action for

EMS agencies is fully described in Mich Admin Code R

325.22126.

R 330.254(4)

Through the development of a statewide STEMI system This is addressed in other sections of the rule set.

of care listed in section (4), we suggest the addition of

additional criteria that would incorporate national

standards, like developing another registry and

adopting national certification standards to make the

program more efficient and cost-effective.

Public Hearing

R 330.255

General

R 330.205 seems to conflict with the State’s certificate CON is not noted in the Rule document. The proposed

of need for PCI. Can the State designate, verify, certify, rules do not supercede CON requirements and CON

or accredit STEMI receiving center Level 1 or 2 if the rules address this issue.

hospital hasn’t met CON?

Additionally, we suggest removing CON to ensure it

CON is not noted in the Rule document. The proposed

aligns with certification criteria. There are some CON rules do not supercede CON requirements and CON

requirements, including protocols, data collection

and measures that may need to be addressed. CON

for PCI without SOS requires accreditation for

cardiovascular excellence, accreditation, or an

equivalent body to perform an onsite review.

rules address this issue.

Public Hearing

R 330.356

In R 330.206, the language should read “Level 1,

TG…TJCHA comprehensive STEMI center or Level 2,

It is R 330.356. The definitions STEMI receiving center

and STEMI referral described in the Rule language

TJCHA primary heart attack center or ACC pain center” were drafted and outlined in the White Paper by the

because it will align with stroke and trauma levels.

Expert Writing group and published on the SOC

website, presented to the EMSCC, and reviewed by

content experts at a statewide meeting in September

2022.

Public Hearing

Unclear on which rule In subsection (i), STEMI receiving centers will need to CON is not noted in the Rule document. The proposed

this is referencing?

comply with CON regulations. Those are not

mentioned here.

rules do not supercede CON requirements and CON

rules address this issue.

Section (b) should read “Level 3 TJCHA acute heart

The definitions STEMI receiving center and STEMI

attack ready center, or ACC non-PCI chest pain center” referral described in the Rule language were drafted

because it will align with the stroke and trauma

levels.

and outlined in the White Paper by the Expert Writing

group and published on the SOC website, presented to

the EMSCC, and reviewed by content experts at a

statewide meeting in September 2022

Public Hearing

In section (8) we believe there is a mismatch between CON is not noted in the Rule document. The proposed

the rules in CON, which limits the number of facilities rules do not supercede CON requirements and CON

that can do PPCI STEMI receiving centers.

rules address this issue.

Additionally, the use of the word “level” should align The definitions STEMI receiving center and STEMI

with our Level 1, 2, and 3 in administrative language referral described in the Rule language were drafted

to demonstrate they exist.

and outlined in the White Paper by the Expert Writing

group and published on the SOC website, presented to

the EMSCC, and reviewed by content experts at a

statewide meeting in September 2022

Public Hearing

General comment

To effectively effectuate a STEMI system of care in

Michigan, it is necessary to interface with Get with

the Guidelines

A common set of data elements and corresponding

data dictionary that interfaces with all three systems

and EMS patient care records and allows for file

transfer to other databases is outlined in A Statewide

System of Care for Time Sensitive Emergencies The

Integration of Stroke and STEMI Care into the Regional

Trauma System (pg16) and included in the current

Request for Proposal for a contract with a company

who can provide this.

David Fuller, Corazon

Public Hearing

General comment

regarding

accredidation.

Currently, the proposed rule includes language that a That process will be outlined in policy and as noted in

provider would need to gain accreditation by a

Department-approved, nationally recognized

the Rules 320.206 Rule 6 (4)(a)…as approved by the

department with the advice of the STEMI advisory

professional certifying and accreditation, accrediting subcommittee pursuant to R 330.204(1)(1) and all the

organization. But it includes no information as to

how such organizations are approved.

following[.]

General comment

regarding

accreditation.

The proposed rule then lists two organizations for

this accreditation, yet amidst Corazon is a named

provider despite our approved standing as an

approved cardiovascular accrediting body by the

Michigan Department of Health and Human Services,

and our ability to meet or exceed the equivalent

criteria maintained by the other named

DHHS has changed these rules to the following

language: 206(4)(a): ...or a Corazon

PCI/Catheterization program[.] and 206(4)(b) : or a

Corazon chest pain center[.}

organizations. This omission is already created

confusion among Corazon’s Michigan accredited

programs in terms of what the differences will be

between the proposed STEMI accreditation and the

current PCI accreditation requirements that already

include the necessary quality and safety monitoring

for the STEMI patient population.

Public Hearing

R 330.206(4)(a) and (b) We request, request that paragraph (6)(4)(a) and (b) DHHS has changed these rules to the following

be amended to include Corazon PCI and chest pain

center accreditation as recognized STEMI and

language: 206(4)(a): ...or a Corazon

PCI/Catheterization program[.] and 206(4)(b) : or a

receiving, and referral center accreditation because Corazon chest pain center[.}

our experience and current accreditation process and

requirements are already used by many Michigan

hospitals.

Dr. Abed Asfour, MD, Corewell Health

East and West

Response to previous I don’t think STEMI and stroke and trauma are the

Recognition of a STEMI begins with an EKG and

symptom recognition. The EMS protocol Michigan

trauma, you can identify it; stroke, 90% or more, it’s Adult Cardiac Chest Pain/Acute Coronary Syndrome

testimony.

same when it comes to chest painers, because

identified that it’s a stroke. STEMI or chest pain for

every, chest for every probably thousand chest

Step 2 states Obtain 12 lead as early as possible

without delaying medication administration (MDHHS

painers, there less than one STEMI. So, if we’re going approval 6/3/2023). As noted, STEMI's are time

to shift ambulances and move them away from local sensitve emergencies similiar in some aspects to

hospitals to just credential places, we are shifting the trauma and stroke requiring the right patient gets the

whole business.

right resource at the right time.

Alex Bou Chebl, MD, FSVIN

Director, Harris Comprehensive Stroke

Center Director, Division Vascular

Neurology

Chair, System Stroke Council

Henry Ford Health

Written

General comment

Henry Ford Health also recommends a more

consistent use of the terms "council", "committee",

and "subcomittee" throughout the rules for uniformity terms and their use were taken directly from the

and to remove any confusion.

DHHS opposes this recommendation. Integration

requires consistent use of terms and definitions. The

established Trauma System rules, and were agreed

upon by the stakeholders and professional subject

matter experts that drafted this rule set.

General comment

In both rules, there does not appear to be a Rule 4.

We request clarification whether this is due to a

missing section or simply a numbering error.

Numbering error. DHHSl correct on final document.

Ryan J. Reece, MD, EMT-P, FACEP

Assistant Professor of Emergency

Medicine

Hurley Medical Center Division

University of Michigan

Written

General comment

I'd like to see 'MCA Medical Director' language used

in these rules. They use generic 'physician(s)' for

committees that advise the State; they need specificity R 325.127. Rule 3(h) which supports the intended

- vascular neurology for stroke system; interventional system integration by including broad stakeholder

cards for STEMI system - MCA MD for both, etc.As you titles: MCA personnel, emergency medical services

DHHS opposes this comment.The Regional Advisory

Council membership is modeled on Mich Admin Code

know, EMS physicians have the experience and

(EMS) personnel, life support agency representatives,

knowledge to support these systems of care uniquely health care facility representatives, physician, nurses

from other types of physicians.

and consumers to avoid being over prescriptive and

inadvertently exclusive of an important

Therefore, I recommend using specific language in the partner/stakeholder. Policy will further refine roles

administrative rules to include EMS physicians and with stakeholder input as described in A Statewide

Medical Control Authority Medical Directors. These System of Care for Time Sensitive Emergencies: The

such physicians will be necessary to oversee and

advise the Department on the systems of care.

Integration of Stroke and STEMI Care into the Regional

Trauma System. It is expected that the content experts

on the advisory council and committee are members

of and/or participate with national organizations and

can reflect the current position of these bodies as it

relates to the state.

Frank Edward Ryan, JD, Senior Advisor, Written

State Government Affairs-American

College of Cardiology

R 330.204; R 330.209 Accordingly, moving forward, we want to ensure that Systems function to enhance efficiencies, coordinate

changes to the system do not produce duplication of and integrate to provide timely quality care. The

tasks. For example, Rule 5 calls for implementation of Trauma System has a statewide patient registry. The

an “all-inclusive STEMI system throughout this state STEMI system of care will integrate data collection in

that allows for the care of all STEMI patients in an

integrated system of healthcare in the pre-hospital

and healthcare facility environments by personnel

that are well trained and equipped to care for STEMI

patients.” Allowing the use of an existing national

data collection tool to be substituted for developing

one de novo would prevent task duplication to the

benefit of patients and practices. This also applies to

Rule 9 (1) – which calls for a new, statewide registry.

(See NCDR Natl CV Data Reg

a statewide data collection tool.

Collin McDonough, Michiga Government Written

Relations Director-American Heart

Association.

R 330.201

(1)(i): “Disciplinary action” should include EMS

agencies. “’Disciplinary action’ means an action

taken by the department against a healthcare facility, EMS agencies is fully described in Mich Admin Code R

EMS agency, or a regional STEMI network for failure 325.22126.

to comply with the code, rules, or protocols approved

DHHS opposes this suggestion. EMS regulations are

addressed in the EMS rule set. Disciplinary action for

by the department.

Written

R 330.203(1)(a)

(1)(a): Align the definition of PCI with the definition

from the CON Review Standards for Cardiac

Catheterization Services: “’Percutaneous coronary

intervention’ (PCI) means a therapeutic cardiac

The definition wasdrafted and agreed upon by the

stakeholders and clinical subject matter experts that

helped draft these rules. The definition was left broad

to ackowledge the potential for changes in the

catheterization procedure to resolve anatomic and/or standard of care based on updated evidenced based

physiologic problems in the coronary arteries of the standards.

heart. A PCI session may include several procedures

including balloon angioplasty, atherectomy, laser,

stent implantation and thrombectomy. The term does

not include the intracoronary administration of

drugs, FFR or IVUS where these are the only

procedures performed.” (Page 3).

Written

R 330.203(1)(k)

(1)(k): For the “Statewide STEMI care advisory

DHHS opposes part of this comment. The Regional

subcommittee,” the Association believes a statement Advisory Council membership is modeled on Mich

such as, “professional organization with expertise in Admin Code R 325.127. Rule 3(h) which supports the

STEMI systems of care like the American Heart

Association” would be appropriate.

intended system integration by including broad

stakeholder titles: MCA personnel, emergency medical

services (EMS) personnel, life support agency

representatives, health care facility representatives,

physician, nurses and consumers to avoid being over

prescriptive and inadvertently exclusive of an

important partner/stakeholder. Policy will further

refine roles with stakeholder input as described in A

Statewide System of Care for Time Sensitive

Emergencies: The Integraration of Stroke and STEMI

Care into the Regional Trauma System. It is expected

that the content experts on the advisory council and

committee are members of and/or participate with

national organizations and can reflect the current

position of these bodies as it relates to the state.

DHHS agrees with the comment regarding the stroke

nurse and Get with the Guidelines comment. The

stroke nurse will be addressed in policy and the

GWTG issue will be addressed in the contract

specifications.

Written

R 330.203(1)(m)

R 330.203(1)(p)

(1)(m): Remove the word “comprehensive” in the

definition of “Statewide STEMI system of care.”

The definition was agreed upon by the stakeholders

and professional subject matter experts that drafted

these administrative rules.

(1)(p): Remove the words “education, risk reduction, The definition of STEMI care was drafted by stake

and subacute.” These actions seem to be beyond the holders and professional subject matter experts to

scope of the administrative code and capabilities of define the care that is provided by the facilities.

the Bureau.

These are programmatic standards that are used to

measure the care provided by accredited and certified

STEMI facilities.

Written

R 330.204(1)(e)

R 330.204(4)

(1)(e): The Association would like to see inclusion of The statement is develop and in-state process…based

TJC-AHA and/or a nationally recognized certifying

body, as deemed by the Department

on a department approved nationally recognized

professional certifying and accreditating

orgnaization.

(4): We recommend additional criteria that would

incorporate national standards, such as developing

another registry and adopting national certification

standards.

This is addressed in other sections of the rule set.

Written

R 330.205

This section would likely need to address protocols, CON is not noted in the Rule document. The proposed

data collection, and measures with CON

requirements.

rules do not supercede CON requirements and CON

rules address this issue.

R 330.206(4)(a)

(4)(a): AHA would like to see designation of Levels for The STEMI Receiving Center and STEMI Refering

the centers. This will allow for future development of Facility nomenclature defined in section R 330.206

the system of care—particularly for patients with

STEMI that evolve to cardiac arrest and/or

cardiogenic shock.

were developed and agreed upon by the stakeholders

and clinical subject matter experts that helped draft

the rules. This recommendation was informed by the

white paper A Statewide System of Care For Time

Sensitive Emergencies: The Integration of Stroke and

STEMI Care into the Regional Trauma System and the

sentinel paper Regional Systems of Care for Patients

With ST-Elevation Myicardial Infarction: Being at the

Right Place at the Right Time witten by Jacobs (2007).

Written

R 330.206(4)(a)(i)

R 330.206(4)(b)

(4)(a)(i): STEMI receiving facilities will need to comply CON is not noted in the Rule document. The proposed

with CON regulations, which are not mentioned here. rules do not supercede CON requirements and CON

rules address this issue.

(4)(b): The Association asks for the use of Levels when A 2-Level STEMi system was distincatly expressed by

referencing facilities. This will allow for future

content experts citing concerns for EMS being

development of the system of care—particularly for challenged to identfy the needs of echmo/baloon

patients with STEMI that evolve to cardiac arrest

and/or cardiogenic shock.

pump patients in the field.

Dr. Natalie L. Baggio

SVP, Patient Care Services

Corew ell Health South

Joshua Kooistra Chief Medical Officer

Corew ell Health West

Written

General

Specifically, we find the following requirements and Certification/Accreditation provides verification of

provisions burdensome: 1) requiring STEMI receiving resources needed to care for STEMI patients at that

AND referral centers to obtain certification or

accreditation by nationally recognized professional healthcare systems across the state crafted the

organizations, 2) the language surrounding recommendations and reviewed and supported the

paricular level. The content experts that represent

accreditation organizations, and 3) the overarching Administrative Rule language.

burden some of the requirements will place on some

of our smaller/rural facilities.

Written

R 330.206(4)(b)

The process of obtaining and maintaining

The Department has been charged with integration of

certification or accreditation from MDHHS-approved the STEMI System of Care into the existing trauma

organizations adds a significant administrative

system. Part of that charge is developing a process

burden to healthcare facilities, without evidence such for designation of facilites. The stakeholders and

accreditation would enhance the quality of care

provided. The accreditation process often involves

professional subject matter experts that helped to

draft these rules agreed that the process outlined in A

extensive documentation and site visits taking away Statewide System of Care For Time Sensitive

valuable staff time and resources that could be better Emergencies: The Integration of Stroke and STEMI Care

utilized delivering patient care and improving

outcomes.

into the Regional Trauma System including verfication

of the level of care provided at each facility by written

proof of certification or accreditation through a

professional-nationally recognized organization

would help to establish a minimum standard of care

in the state. According to the American Heart

Association System of Care for ST-Segment Elevation

Myocardial Infarction: A Policy Statement from the

AHA "STEMI referring hospitals and STEMI receiving

centers have specific roles in a STEMI system of care,

and each should be as prepared as possible to

collaboratively perform evidence-based, lifesaving

treatment." Accreditation is the process that identifies

bli h

ibili

Written

General regarding

accreditation

Requiring additional accreditation for cardiac

catheterization (cath) labs and chest pain centers

Accrediation/certification standards for a STEMI

Receiving Center are not confined to the cath lab only,

could be redundant and not necessarily indicative of but to ensure a full program of policies, procedures,

improved patient outcomes.

data collection,education, performance improvement

is in place to ensure quality care.

General regarding

accreditation

An additional unanticipated outcome is the

incorporation of STEMI treatment under the Chest

Pain category within the framework of the

accreditation process. This policy will redirect

ambulance transfers away from facilities lacking

accreditation, channeling them exclusively to

accredited establishments. Consequently, this may

induce a concentration of chest pain cases solely

Delays in treatment correspond to increases in

mortality (a delay of 121-180 minutes corresponded

to a mortality rate of 28% in a study published in

JAMA in 2010 Aug 18; 304(7):763-71. Systems are

designed to ensure the STEMI patient gets to the

closest appropriate resource as soon as possible.

Not knowing what the resources are (not certified or

accredited) would have EMS providers bringing

within accredited hospitals, potentially creating an patients to facilities that may not have the necessary

advantage for one emergency department while

placing undue strain on another and excluding a

third.

resources, requiring transfer, delaying care and

increasing the risk of a poor outcome.

Written

General regarding

accreditation

Finally, requiring referral facilities to obtain

accreditation is a costly proposal. We at Corewell

Health have numerous rural facilities that are

Content experts included rural facilities, resource

implications were discussed and the experts advised

that the potential to improve care and outcomes and

already sending STEMI and suspected STEMI patients return Michiganders to a productive life were of

to facilities that would or potentially qualify as

receiving centers. Requiring a facility, especially

rural facilities, to obtain accreditation may make this

designation unobtainable.

significant benefit.

Accrediting Bodies

Corewell Health appreciates the Bureau of Emergency DHHS has changed these rules to the following

Language - R 330.206 Preparedness, EMS, and Systems of Care’s efforts to language: 206(4)(a): ...or a Corazon

Rule 6(4)(a); R 330.206 offer broad language related to approved accrediting PCI/Catheterization program[.] and 206(4)(b) : or a

Rule 6(4)(b).

bodies. We also understand that no final decisions

have been made related to the accrediting bodies.

However, we believe that the Corazon accreditation

should be recognized as a valid and valuable

alternative, for facilities without on-site Open-Heart

Surgery (OHS) services.

Corazon chest pain center[.}

Written

Administrative Burden Requiring additional accreditation for cath labs and The Department has been charged with integration of

– R 330.201 – R

330.214

chest pain centers could be redundant and not

necessarily indicative of improved patient outcomes. system. Part of that charge is developing a process

Facilities with mature on-site Open OHS services for designation of facilites. The stakeholders and

the STEMI System of Care into the existing trauma

already possess a higher level of readiness to handle professional subject matter experts that helped to

complex cases. OHS services ensure that emergency draft these rules agreed that the process outlined in A

interventions can be carried out promptly. Therefore, Statewide System of Care For Time Sensitive

it might be worth reconsidering the need for

Emergencies: The Integration of Stroke and STEMI Care

additional cath lab or chest pain center accreditation into the Regional Trauma System including verfication

for such facilities, as the existing capabilities align of the level of care provided at each facility by written

with STEMI care goals.

proof of certification or accreditation through a

professional-nationally recognized organization

would help to establish a minimum standard of care

in the state. The Department will be collaborating with

the current accreditation processes for Cath Labs.

SCAI Expert Consensus Statement on PCI without On-

Site Surgical Back-up reported a <0.1% rate of

emergent bypass surgery post PCI. Open Heart Surgery

as treatment for a STEMI is an important option, not

the primary method of treatment, surgically capable

facilites are vital partners in the system.

Karen Hartman

President & CEO

Corazon, Inc.

5000 McKnight Road, Suite 300

Pittsburgh, PA

Written

General regarding

accreditation

Despite Corazon’s standing as an approved

DHHS has changed these rules to the following

cardiovascular accrediting body by MDHHS, Corazon language: 206(4)(a): ...or a Corazon

was omitted from the proposed rule language. In fact, PCI/Catheterization program[.] and 206(4)(b) : or a

the rule language includes no information as to how Corazon chest pain center[.}

the named organizations were approved by MDHHS to

David H. Fuller

be included in the proposed rule or how other

Executive Vice President, Accreditation

Corazon, Inc.

organizations may be approved in the future.

5000 McKnight Road, Suite 300

Pittsburgh, PA 15237

Written

General regarding

accreditation

Two significant concerns related to pursuing new

accreditations, particularly when related to a

regulatory requirement, are the cost burden to the

hospital and the timeliness of being able to achieve

accreditation.

No response needed.

Written

R 330.206

Based on the information presented, Corazon, and our DHHS has changed these rules to the following

clients, request that in R 330.206 Paragraphs 6(4)(a) language: 206(4)(a): ...or a Corazon

and 6(4)(b) be amended as follows to include Corazon PCI/Catheterization program[.] and 206(4)(b) : or a

PCI and CPC accreditations as recognized STEMI

receiving and referral center accreditations,

respectively, to proactively meet the requirements of

the proposed rule, avoid confusion, and avert

additional spending that could otherwise be

necessary.

Corazon chest pain center[.}

Henry Kim, MD, MPH, FACC

System Chief of Cardiology

Henry Ford Health

Division Head, Cardiology

Frank and Barbara Darin Chair

Edith and Benson Ford Heart and

Vascular Institute

Written

R 330.206

Amend Rule 6. (4) (a) to add "Corazon Cath/PCI

DHHS has changed these rules to the following

Program" as an additional qualifying certifying and language: 206(4)(a): ...or a Corazon

accrediting organization for a STEMI receiving center. PCI/Catheterization program[.] and 206(4)(b) : or a

Corazon chest pain center[.}

Henry Ford Hospital

Ryan J. Reece, MD, FACEP

Assistant Professor of Emergency

Medicine

General comment

There should be rules outlining methods to optimize Cardiac arrest is certainly an important condition

the 'Chain of Survival'. In the realm of 'time-sensitive that should be managed timely. There are already

emergencies', there's trauma, STEMI, stroke, and

many stakeholders in the state engaged in addressing

Hurley Medical Center Division

University of Michigan

cardiac arrest. All of these conditions' outcomes are cardiac arrest (saveMiheart ) that are invested in

directly related to timeliness in recognition,

response, treatment, transporting to the most

providing education (bystander CPR, ALS, BLS), AED’s,

collecting data (CARES registry), implementing

appropriate facility, and system QI/QA activities. For protocol and guideline driven care. There will be

me, it makes sense to write in language related to

cardiac arrest care in the STEMI rules as these

conditions are often related.

many opportunities for the STEMI system to intersect

and collaborate with these groups invested in caring

for those patients who have experienced cardiac

arrest, particular those ROSC (return of spontaneous

circulation) patients. Unfortunately, national data

from the 2020 CARES report

https://mycares.net/sitepages/uploads/2021/2020_fli

pbook/index.html?page=32 states that 42.4% of

patients with cardiac arrest are pronounced at the

scene after resuscitative efforts were terminated and

of those that did survive to be transported to a

hospital the rate of survival to hospital discharge as

9.0%. The investment in STEMI care that manages risk

factors, requires prompt treatment, care and follow-

up demonstrates a commitment to limiting the number

of Michigan residents who experience cardiac arrest

and a poor outcome.

Alex Bou Chebl, MD, FSVIN

Director, Harris Comprehensive Stroke

Center Director, Division Vascular

Neurology

Chair, System Stroke Council

Henry Ford Health

Written

General comment

R 330.204

Henry Ford Health also recommends a more

consistent use of the terms "council", "committee",

and "subcommittee",

DHHS opposes this recommendation. Integration

requires consistent use of terms and definitions. The

terms and their use were taken directly from the

established Trauma System rules, and were agreed

upon by the stakeholders and professional subject

matter experts that drafted this rule set.

Numbering error. This will be corrected in the final

rule set.

In both rules, there does not appear to be a Rule 4.

We request clarification whether this is due to a

missing section or simply a numbering error.

Dr. Ivan Hansen, Medical Director of

Cardiac Catheterization Laboratory at

William Beaumont University Hospital,

Corewell East

Public Hearing

General Questions and And are there any concerns about using that

Answers distinction for STEMI specifically since STEMI care

The other thing that we are very clear about saying is

we understand the geography is porous, and that

involves considerably different resources than some patients flow is, can be conscribed by that piece of

of those other systems of care?

geography. However, we needed a structure so that

the groups can sit in some sort of an arranged

fashion. So, that’s why we added the layers to the

preparedness region. So, the systems discuss care in

their geography with a loose affiliation understanding

patients can ebb and flow. And they can also talk

amongst each other, the eight regions can talk to each

other. They have an organizational structure like that.

Public Hearing

General Questions and How is the advisory committee chosen?

Answers

An application. There are some titles that we’d like to

see represented on those advisory committees and,

once there are submitted applications, we will look at

them all we’ll appoint them by then.

General Questions and What you’re saying is that in terms of going forward That's correct.

Answers

should this pass, then they’ll be an application

process for an advisory committee.

Public Hearing

General Questions and What is the estimated overall cost of this proposal

Answers should it be implemented overall.

General Questions and And the cost of each participating center or…?

Answers

The budget is $3 million.

We don’t charge a fee. We don’t charge anything, and

our plan is in the RFP for the data, the IT project is

that data entry would be free for them. It would allow

them access to our system for no charge. No charge to

them, it will cost us money, not them.

Public Hearing

General Questions and The program will be funded by taxpayer dollars or

General Fund

Answers

grant?

General Questions and In the white paper, there was some verbiage to the

It’s either/or. Or an equivalent. But we wrote that, we

hope, to establish a baseline for standards because

without them, we have anything (inaudible) in terms

of what somebody would say, this is a STEMI facility.

So that was the design is to create a nationally

recognized standards set, however, any entity that can

provide that, or an equivalent, or the advisory body

tells us this is equivalent, that will be something we

would accept.

Answers

effect that its recommended that participating

hospitals or centers be accredited by both joint

commission/AHA and ACC, did I understand that

correctly?

Public Hearing

Written

General Questions and What about centers in my region of Southeast

Answers

Not much, in terms of delivery, once the resources are

Michigan where we have multiple STEMI centers. How categorized, the pre-hospital world understands who

would this regulation impact us?

has what resources, that is, a provider in the field at

the minute decision about whether or not they get an

airway, whether or not the closest appropriate is-, you

know, and I know the resources are at this particular

building. That is something that protocol and the pre-

hospital provider will have that information, that very

important information, to deliver those services. And

that’s the fundamental reason to do this. Categorizing

resources so the pre-hospital provider and the

sending facility understands where to go down the

road next. That’s often a problem. Who has got the

cath lab that’s 24/7 that doesn’t have an

interventionalist that I need to send them to,

especially in the far-flung areas where they don’t

necessarily know? It’s built on relationships, not

exactly understanding resources. So, categorizing

those really makes it much simpler to make those

decisions. And if things didn’t go well, why not? Let’s

have a conversation in a RPSRO environment where

we can have a good “why didn’t it work and what can

we do better”?

General Questions and For well-established centers that have been providing Well, if we don’t understand your resources, if you

Answers STEMI care for a long time, that choose not to haven’t told us they’ve been categorized by any entity,

participate in accreditation bodies, if this proposal then, then it’s a challenge for us, right? We don’t

passes, what, would there be some type of punitive understand what area you deliver, like, you could be

action against those centers or how would that affect the cath lab that is only has, doing diagnostics and

them?

would we want to stay there or stop there? Not

necessarily ideal for the patient. So, so that is a

consideration. We are also very clear this is

voluntary and inclusive. Those systems are highly

functioning 100% of the time when everybody

participates. However, it is every facility’s decision

whether or not they choose to participate. We cannot

designate you, which is only something a state can do,

so not only are you accredited but are designated by

the State of Michigan as a particular level of facility.

We can’t do that unless we’ve had some sort of

process that verifies you do have the resources that

you say you do. So, this is an effort to codify what we

already know what the trauma surgeons are very

confident about; that they have to deliver those

services. The other thing we want to do is to talk about

it from a system perspective. The EMS provider

already knows that appropriately. Did they get to

right place, do they have the right resources, was the

care delivery the way you hoped it would be? If not,

why not? Talk to your group, talk to your mentors, talk

to your other building surgeons

how can we do this

Rosalie Tocco Bradley, Chief Clinical

Officer, Trinity Health

330.206(4)(a) and (b) Unless the Department or the Bureau has found gaps DHHS has changed these rules to the following

in the standards Corazonhas proposed, we request language: 206(4)(a): ...or a Corazon

the proposed rule language be amended as follows: PCI/Catheterization program[.] and 206(4)(b) : or a

Corazon chest pain center[.}

Rule 6. (4) (a) A STEMI receiving center shall provide

evidence of current certification or

accreditation by a department-approved nationally

recognized professional certifying and

accrediting organization that the healthcare facility

has the resources required to be certified as

meeting all the criteria for a certified STEMI receiving

center equivalent to a Corazon Cath/PCI

Program, or a TJC-AHA comprehensive STEMI center or

TJC-AHA primary heart attack center, or an ACC

chest pain center with PCI, or subsequent equivalent

certification or accreditation as approved by

the department with the advice of the STEMI advisory

subcommittee, pursuant to R 330.204(1)(l), and

all the following:

Rule 6. (4) (b) A STEMI referral facility shall provide

evidence of current certification or

accreditation by a department-approved nationally

recognized professional certifying and

accrediting organization that the healthcare facility

has the resources required to be certified as

meet

ng all the criteria for a certified STEMI referral

Michael Church, Corazon

Written

General

Email forwarded comments from Karen Hartman

No comment needed

President & CEO

Corazon, Inc.

and

David H. Fuller

Executive Vice President, Accreditation

Corazon, Inc.-See their comments above.

David Walker, Corewell

Written

General Comment

Email forwarded comments from Dr. Joshua Kooistra No comment needed

and Natalie Baggio, Corewell-See their responses

above.

25 August 2023

Department of Health and Human Services

Public Health Administraꢀon

Administraꢀve Rules for Statewide ST-Elevaꢀon Myocardial Infarcꢀon (STEMI) System Rule Set 2022-61

To whom it may concern:

On August 22^nd, 2023, the American Heart Associaꢀon shared feedback during the hearing on Rule Set

2022-61 HS in Lansing, MI. As indicated in the tesꢀmony, these comments were to be a precursor to our

formal, wriꢁen tesꢀmony. Please see our recommended changes below.

The American Heart Associaꢀon believes the term “STEMI” should be replaced with the term “Heart

Aꢁack.” STEMI is a medical term not oꢂen used or understood by the public. This includes the deﬁniꢀon

of STEMI receiving and STEMI referral, which should use other terms that hospitals may uꢀlize to

adverꢀse themselves as providing STEMI/heart aꢁack care, such as heart aꢁack and chest pain center.

The Associaꢀon believes any successful plaꢃorm will integrate with Get with The Guidelines (GWTG)®.

This includes exportaꢀon for STEMI data collecꢀon to GWTG®-Coronary Artery Disease.

R. 330.201

•

(1)(i): “Disciplinary acꢀon” should include EMS agencies. “’Disciplinary acꢀon’ means an acꢀon

taken by the department against a healthcare facility, EMS agency, or a regional STEMI network

for failure to comply with the code, rules, or protocols approved by the department.

R 330.203

•

(1)(a): Align the deﬁniꢀon of PCI with the deﬁniꢀon from the CON Review Standards for Cardiac

Catheterizaꢀon Services: “’Percutaneous coronary intervenꢀon’ (PCI) means a therapeuꢀc

cardiac catheterizaꢀon procedure to resolve anatomic and/or physiologic problems in the

coronary arteries of the heart. A PCI session may include several procedures including balloon

angioplasty, atherectomy, laser, stent implantaꢀon and thrombectomy. The term does not

include the intracoronary administraꢀon of drugs, FFR or IVUS where these are the only

procedures performed.” (Page 3).

•

(1)(k): For the “Statewide STEMI care advisory subcommiꢁee,” the Associaꢀon believes a

statement such as, “professional organizaꢀon with experꢀse in STEMI systems of care like the

American Heart Associaꢀon” would be appropriate.

•

(1)(m): Remove the word “comprehensive” in the deﬁniꢀon of “Statewide STEMI system of

care.”

(1)(p): Remove the words “educaꢀon, risk reducꢀon, and subacute.” These acꢀons seem to be

beyond the scope of the administraꢀve code and capabiliꢀes of the Bureau.

R 330.204

•

(1)(e): The Associaꢀon would like to see inclusion of TJC-AHA and/or a naꢀonally recognized

cerꢀfying body, as deemed by the Department.

(4): We recommend addiꢀonal criteria that would incorporate naꢀonal standards, such as

developing another registry and adopꢀng naꢀonal cerꢀﬁcaꢀon standards.

R 330.205

•

This secꢀon would likely need to address protocols, data collecꢀon, and measures with CON

requirements.

R 330.206

•

(4)(a): AHA would like to see designaꢀon of Levels for the centers. This will allow for future

development of the system of care—parꢀcularly for paꢀents with STEMI that evolve to cardiac

arrest and/or cardiogenic shock.

•

(4)(a)(i): STEMI receiving faciliꢀes will need to comply with CON regulaꢀons, which are not

menꢀoned here.

(4)(b): The Associaꢀon asks for the use of Levels when referencing faciliꢀes. This will allow for

future development of the system of care—parꢀcularly for paꢀents with STEMI that evolve to

cardiac arrest and/or cardiogenic shock.

For any quesꢀons or follow-up, please contact:

Collin McDonough

Michigan Government Relaꢀons Director

American Heart Associaꢀon

Collin.McDonough@heart.org

(231)675-4326

From:

To:

Ryan J. Reece, MD, FACEP

MDHHS-AdminRules

Subject:

Date:

Comment on STEMI Admin Rules; Incorporating Cardiac Arrest Language

Wednesday, July 26, 2023 11:15:08 AM

CAUTION: This is an External email. Please send suspicious emails to

abuse@michigan.gov

Greetings,

The STEMI system of care should incorporate best practices regarding cardiac arrest care.

There should be rules outlining methods to optimize the 'Chain of Survival'. In the realm of

'time-sensitive emergencies', there's trauma, STEMI, stroke, and cardiac arrest. All of these

conditions' outcomes are directly related to timeliness in recognition, response, treatment,

transporting to the most appropriate facility, and system QI/QA activities. For me, it makes

sense to write in language related to cardiac arrest care in the STEMI rules as these

conditions are often related.

Here's a link to resources from the Resuscitation Academy

(https://www.resuscitationacademy.org/); an organization whose mission is to improve

cardiac arrest care.

https://drive.google.com/drive/folders/1L5S1Pdkh_CQm5vQLxCE4hCfbIy3cW5HV?

usp=sharing

I'd be happy to talk more about these suggestions if that would be helpful. I, unfortunately,

will be out of town on the day of the open meeting.

Best regards,

Ryan

Ryan J. Reece, MD, FACEP

Assistant Professor of Emergency Medicine

Hurley Medical Center Division

University of Michigan

Email: rreece2@hurleymc.com

Office: (810) 262-9854 | Fax: (810) 760-0853

Cell: (248) 660-7282

CONFIDENTIALITY AND PRIVACY NOTICE

This message may contain confidential information protected by law through attorney-client privilege or professional

peer review/quality evaluation privilege and is intended for use only by the individual or entity to which it is addressed,

and may contain information that is private, privileged, confidential or exempt from disclosure under applicable law

including; MCL 330.1143A, MCL 330.1748, MCL 331.531, MCL 331.532, MCL 331.533, MCL 331.20175, MCL

333.21513, MCL 333.21515 and other applicable laws. It is prohibited for anyone else to disclose, copy, distribute, or

use the contents of this message. Receipt by anyone other than the named recipient(s) is not a waiver of any attorney-

client, work product, or other applicable privilege. If you are not the intended recipient, please contact the sender by

reply e-mail and destroy all copies of the original message.

August 25, 2023

Ms. Mary Brennan

Interim Director and Regulatory Affairs Officer

Bureau of Legal Affairs

Ms. Eileen Worden

State Trauma Manager

Bureau of Emergency Preparedness, EMS, and Systems of Care

Michigan Department of Health and Human Services

333 S. Grand Avenue

P.O. Box 30195

Lansing, MI 48909

Subject: Statewide STEMI System R 330.201 – R 330.230 (Pending Rule Set 2022-61 HS)

Department Representatives,

Corazon is writing in support of our clients who are Michigan hospitals maintaining active

cardiovascular accreditations with Corazon and to request minor changes to the pending

administrative rule set 2022-61 HS regarding establishing a statewide STEMI system of

care. Corazon supports the need for a statewide STEMI system of care to support the

health and wellbeing of Michiganders by enhancing standardization and providing greater

certainty for first responders and communities related to the care provided at hospitals

across the state.

Corazon has long been an expert in the field of cardiovascular program development and

management and is in its 10^thyear as an accrediting body for cardiovascular programs

across the country. Corazon provides accreditation for interventional cardiology (PCI),

Chest Pain Center (CPC), electrophysiology (EP), peripheral vascular intervention (PVI),

open heart surgery (OHS), transcatheter aortic valve replacement (TAVR), and heart

failure (HF) programs. Corazon accreditation services are endorsed by the Society for

Coronary Angiography and Interventions (or SCAI), the leading non-profit medical society

for invasive and interventional cardiology, founded in 1978. Additionally, Corazon has

been recognized by the Michigan Department of Health and Human Services

(MDHHS) as an accrediting body under the existing CON Review Standards for

Cardiac Catheterization Services since 2015, demonstrating an ongoing commitment

to the health and safety of patients and communities across this state. As an approved

accrediting body, MDHHS has recognized Corazon’s ability to comply with state

requirements to monitor cardiovascular program quality.

In addition to Michigan, Corazon has been recognized by other states that require

ongoing oversight for various cardiovascular programs, including, but not limited to:

• Florida Agency for Health Care Administration: Since 2009, Corazon has

supported hospitals pursuing Level I or Level II Licensure for Adult Cardiovascular

Services through an attestation process.

• Georgia Department of Community Health: Since 2005, Corazon has been

recognized as a third-party verification entity to confirm programs seeking to offer

PCI services have met the requirements outlined in the applicable regulations.

• Pennsylvania Department of Health: Since 2013, Corazon has been recognized

as a named accrediting body for PCI programs with offsite OHS backup, as

required in the established PCI exception procedure language.

• New Jersey Department of Health: Since 2019, Corazon has been an approved

third party to assist providers in developing performance improvement plans to

maintain PCI services and comply with the state’s defined quality requirements.

• Nationally, Corazon supports hospitals of all sizes in pursuing service expansion

with an emphasis on ensuring program quality and compliance with all applicable

regulatory requirements. For providers that elect to forego program accreditation,

Corazon conducts assessments prior to program expansions to ensure readiness

of the staff, adequacy of resources, and dedication to quality and patient safety.

Corazon has long recognized the importance of standardizing STEMI care by

incorporating STEMI procedures and protocols into its current PCI and CPC accreditation

standards. This includes the ability of hospitals to appropriately manage STEMI and

suspected STEMI patients with an emphasis on timely identification, treatment, and

evidence-based medical decisions. In addition to reviewing providers’ standards and

protocols, Corazon’s PCI and CPC accreditations require quarterly submission of key

clinical outcomes data, including indices related to the timely treatment or transfer of

STEMI patients. As you are likely aware, “time is muscle” when it comes to treating STEMI

patients, and the importance of these critical timeframes to achieve optimal outcomes has

always been present in Corazon’s accreditation standards.

Corazon’s STEMI requirements are based on the same clinical guidelines and best

practices as the other accrediting organizations that are named in the proposed rule, as

well as Corazon’s experience working with more than 750 hospitals across the country.

In addition to Corazon’s work as an accrediting body for the last 10 years, the firm has

provided consultative services to support cardiovascular program development for more

than 20 years. In its history, Corazon has supported more than 85 providers in the

development of new PCI and STEMI programming.

The STEMI standards included in Corazon accreditation include requirements related to

program readiness 24 hours per day, 7 days per week; access to emergency services;

and the availability of cardiology expertise, as appropriate to the designated level of care.

As part of its accreditation process, Corazon ensures medical providers maintain good

standing and experience in line with current practice recommendations from medical

societies. Corazon actively participates in ongoing quality improvement efforts, including

participation in quality meetings while onsite, validation of quality infrastructure, and

ongoing quarterly review of program outcomes.

These requirements match or exceed what is included within the published standards of

the two organizations named in the proposed rule as “department-approved nationally

recognized professional certifying and accrediting organizations.” Despite this, and

despite Corazon’s standing as an approved cardiovascular accrediting body by MDHHS,

Corazon was omitted from the proposed rule language. In fact, the rule language includes

no information as to how the named organizations were approved by MDHHS to be

included in the proposed rule or how other organizations may be approved in the future.

This omission has already created confusion among Corazon’s Michigan accredited

programs in terms of what the differences will be between the proposed STEMI

accreditation and their current PCI accreditation which already includes the necessary

quality and safety monitoring required for STEMI patients. There are also concerns

related to confusion this may cause within the communities served by these providers,

with EMS providers in the state, and possibly even within MDHHS as to the good standing

of these programs if Corazon accreditation is not proactively recognized. In speaking with

our Michigan-based accreditation clients, we collectively want to be assured there will be

no additional financial or procedural burden placed on them by requiring an additional

accreditation beyond what they already maintain.

Similarly, it is important to note that Corazon accreditation does not require participation

in a specific registry, but can use internal data points or available information from any

registry a hospital participates in. This approach better positions Corazon accreditation to

comply with the proposed rule, as the registry and data collection requirements have not

yet been defined. Additionally, this allows Michigan providers to avoid additional cost

burdens for programs that may not otherwise need to participate in additional registries.

For example, providers may manage CPC outcomes through an internal dashboard,

particularly for a STEMI referral center, while others may already have the required

information available through the Michigan BMC2 registry. From our understanding, the

Michigan BMC2 registry is not currently recognized by the other named accrediting bodies

but would be recognized by Corazon.

Two significant concerns related to pursuing new accreditations, particularly when related

to a regulatory requirement, are the cost burden to the hospital and the timeliness of being

able to achieve accreditation. Corazon has a history of working with providers to ensure

cost effective accreditation services are available based on the size and scope of the

program under review, while also highlighting cost savings opportunities for hospitals that

can be realized with improved efficiencies through the accreditation process. Historically,

Corazon’s wait time to schedule an onsite survey averages just 2 to 4 weeks, compared

to other organizations which may have survey backlogs of 6 months or longer. Corazon

also works with providers to achieve accreditation readiness in the shortest feasible

timeframe, while ensuring quality of care and the ability to demonstrate compliance with

all accreditation standards.

Corazon maintains a national accreditation client base and has the capacity to accredit

any and all of the Michigan providers affected by the proposed rule. Corazon currently

accredits 23 hospitals in Michigan for PCI or CPC services, representing 23 facilities who

would not have to seek an additional accreditation if Corazon is proactively recognized

under the proposed rule. While Corazon’s complete client list is not available publicly,

many programs accredited by Corazon, within Michigan and across the country, are part

of major health systems. A sample of the health systems utilizing Corazon accreditation

includes the following organizations::

Michigan:

• Ascension

• Corewell Health

• Henry Ford Health System

• McLaren Health Care Corporation

• Michigan Medicine

• MyMichigan Health

• Prime Healthcare

• Trinity Health

• Independent Hospitals

Nationwide:

• AdventHealth

• Adventist Health

• Allegheny Health Network

• Atrium Health

• Community Health Systems

• HCA Healthcare

• LifePoint Health

• Main Line Health

• Penn Highlands Healthcare

• Prime Healthcare

• Trinity Health

• UNC Health Care

• UPMC

• WellSpan Health

• WVU Medicine

• Independent Hospitals

Corazon monitors critical quality metrics for all accredited programs. Corazon evaluated

key performance metrics (e.g., major adverse events, percent of patients receiving PCI

within 90 mins, etc.) among its Michigan PCI accreditation clients from 2015 to 2022. This

review demonstrated improvement by all Corazon accreditation clients in at least one

key metric since achieving its accreditation through Corazon. Additionally, 91% report

performance in the 90^thpercentile nationally for multiple key metrics. Finally, 84% of all

individual metrics tracked across all Corazon-accredited PCI programs in Michigan

have improved since initiating accreditation with Corazon. Similar improvements have

been realized by Corazon’s clients outside of Michigan as well. These outcomes

demonstrate the positive impact Corazon accreditation has on the delivery of patient care.

Some of Corazon’s Michigan accreditation clients have submitted comments as well

supporting the assertion that Corazon be recognized in the proposed rule. Those that

have been shared with Corazon are attached to this document.

Through preliminary discussions with representatives from the Bureau of Emergency

Preparedness, EMS, and Systems of Care within MDHHS, Corazon shared its current

standards for PCI and CPC accreditation, summaries of which are attached hereto.

Corazon received positive feedback that these would meet or exceed the goals of the

proposed rule.

Based on the information presented, Corazon, and our clients, request that in R 330.206

Paragraphs 6(4)(a) and 6(4)(b) be amended as follows to include Corazon PCI and CPC

accreditations as recognized STEMI receiving and referral center accreditations,

respectively, to proactively meet the requirements of the proposed rule, avoid confusion,

and avert additional spending that could otherwise be necessary:

Rule 6. (4) (a) A STEMI receiving center shall provide evidence of current certification or

accreditation by a department-approved nationally recognized professional certifying and

accrediting organization that the healthcare facility has the resources required to be

certified as meeting all the criteria for a certified STEMI receiving center equivalent to a

Corazon Cath/PCI Program, or a TJC-AHA comprehensive STEMI center or TJC-AHA

primary heart attack center, or an ACC chest pain center with PCI, or subsequent

equivalent certification or accreditation as approved by the department with the advice of

the STEMI advisory subcommittee, pursuant to R 330.204(1)(l), and all the following:

Rule 6. (4) (b) A STEMI referral facility shall provide evidence of current certification or

accreditation by a department-approved nationally recognized professional certifying and

accrediting organization that the healthcare facility has the resources required to be

certified as meeting all the criteria for a certified STEMI referral facility equivalent to a

Corazon Chest Pain Center, or a TJC-AHA acute heart attack ready center or ACC non-

PCI chest pain center or subsequent equivalent certification or accreditation as approved

by the department with the advice of the STEMI advisory subcommittee, pursuant to R

330.204(1)(l), and all the following:

If needed, Corazon would be happy to provide additional information to MDHHS to verify

the standards included in PCI and CPC accreditation related to STEMI patient care.

We appreciate your attention to this matter and look forward to the positive impact this

system of care can have on patients across the state.

Sincerely,

Karen Hartman

David H. Fuller

President & CEO

Corazon, Inc.

Executive Vice President, Accreditation

Corazon, Inc.

5000 McKnight Road, Suite 300

Pittsburgh, PA 15237

5000 McKnight Road, Suite 300

Pittsburgh, PA 15237

CC: Elizabeth Hertel, Department of Health and Human Services Director

Sarah Lyon-Callo, Senior Deputy Director of Public Health Administration

Jay Fiedler, State Bureau Administrator

David Knezek, Chief Deputy Director of Administration

CORAZON PCI ACCREDITATION

STANDARDS SUMMARY

Corazon interventional cardiology (PCI) Accreditation validates a hospital’s compliance with the

most recent and relevant national society guidelines for the provision of interventional cardiology

services. Corazon Accreditation includes an onsite survey to observe and measure program

operations as well as routine data review to ensure quality metrics are maintained.

Corazon standards are based on both societal guidelines and Corazon’s experience with a

multitude of programs across the country. The following list is a summary of Corazon PCI

Accreditation standards to be evaluated for each program:

•

Pre-hospital care evaluation (in the field evaluation of chest pain/STEMI population, review of

formal agreements with pre-hospital providers, pre-hospital metric evaluation, etc.).

Governance and leadership of the PCI program, including, but not limited to, the medical

director of the PCI program, multi-disciplinary team (which may include ED physicians and

nursing personnel), pre-hospital providers, Cath Lab Manager/Director, STEMI Coordinator,

Data Abstractor, and other key personnel.

•

Formal Heart Team approach for all patients in need of a coronary intervention.

Demonstrated quality infrastructure, including a formal continuous quality improvement (CQI)

initiative and policies to track and monitor program and patient outcomes, including a formal

door-to-balloon (D2B) or STEMI committee for real-time feedback for that patient population.

•

All policies, procedures, protocols, order sets, and patient algorithms associated with the

provision of PCI services.

Appropriateness of equipment and supplies and the ability to appropriately manage patients

for the timely completion of any additional testing for clinical decision making.

Randomly identified PCI patient charts, including elective, urgent, and emergent (STEMI)

patients presenting in the ED or in-house or transferred from a non-primary PCI center.

•

Comprehensive education plan for clinical nursing departments and non-clinical staff.

All community outreach efforts (education forums, pre-hospital collaboration, etc.).

Availability of non-invasive testing, the process for scheduling, and hours of availability.

•

Critical timing metrics specific to the STEMI and nSTEMI patient populations (e.g. critical lab

tests, door to ECG, D2B, door to door transfer, door to fibrolytic therapy, etc.).

•

Way finding specific to the cardiac, PCI, and STEMI patient populations across the facility.

Formal patient follow up processes for patients treated at the PCI center.

CORAZON CHEST PAIN CENTER ACCREDITATION

STANDARDS SUMMARY

Corazon Chest Pain Center (CPC) Accreditation validates a hospital’s compliance with the most

recent and relevant national society guidelines for the management of low, moderate, and acute

chest pain patients. Corazon Accreditation includes an onsite survey to observe and measure

program operations as well as routine data review to ensure quality metrics are maintained.

Corazon standards are based on both societal guidelines and Corazon’s experience with a

multitude of programs across the country. The following list is a summary of Corazon CPC

Accreditation standards to be evaluated for each program:

•

Pre-hospital care evaluation (in the field evaluation of chest pain population, review of formal

agreements with pre-hospital providers, pre-hospital metric evaluation, etc.).

Governance and leadership of the CPC, including, but not limited to, the medical director of

the CPC, Chest Pain or STEMI Coordinator, Data Abstractor, and other key personnel.

Demonstrated quality infrastructure, including a formal continuous quality improvement (CQI)

initiative and policies to track and monitor program and patient outcomes.

•

All policies, procedures, protocols, order sets, and patient algorithms associated with the CPC.

Appropriateness of equipment and supplies and the ability to appropriately manage patients

for the timely completion of any additional testing for clinical decision making.

•

Randomly identified chest pain patient charts.

Comprehensive education plan for clinical nursing departments and non-clinical staff.

All community outreach efforts (education forums, pre-hospital collaboration, etc.).

Availability of non-invasive testing, the process for scheduling, and hours of availability.

Critical timing metrics specific to the chest pain patient (e.g. critical lab tests, door to ECG,

door to balloon, door to transfer, door to fibrolytic therapy, etc.).

•

Way finding specific to the chest pain patient population across the facility.

Formal patient follow up processes for patients treated at or transferred from the CPC.

Corazon Cardiovascular Accreditation Services

Interventional

Cardiology (Cath/PCI)

Accreditation

Cardiovascular Service

Line of Excellence

(CV SLoE) Accreditation

Chest Pain Center (CPC)

Open Heart Surgery

(OHS) Accreditation

Description

Accreditation

Overview

CPC Accreditation focuses

on pre-hospital care and

response, triage, diagnosis,

patient navigation, and

coordination of resources.

Hospitals qualify for this

accreditation by providing

care for patients presenting

with the following:

Cath/PCI Accreditation

evaluates the care provided

to interventional cardiology

patients, including emergent, emergent, urgent, and

urgent, and elective elective procedures.

procedures. Hospitals qualify Hospitals qualify for this

for this accreditation by

providing the following:

• Diagnostic Cardiac

Catheterization

• Elective and Primary

(emergent) Cardiac

Intervention

• Management of

Cardiogenic Shock

Patients (may include

transfer to a tertiary

provider)

• Management of patients

requiring hemodynamic

stabilization (insertion of

IMPELLA or IABP)

• Cardiac Rehabilitation

Services (onsite or

through a partner entity)

OHS Accreditation evaluates Cardiovascular Service Line

the care provided to cardiac

surgery patients, including

of Excellence Accreditation

is awarded to any program

achieving three (3) or more

accreditations through

Corazon. It attests to the

quality of care being

provided across that

hospital’s cardiovascular

services. Three of the

following must be accredited:

• Open Heart Surgery

• Cath/PCI

accreditation by providing

the following:

• Cardiac Surgery

Procedures

• Acute Coronary

Syndrome (ACS)

CABG,

Surgical Valve

Repair/

• ST Elevation Myocardial

Infarction (STEMI)

Replacement

(formal STEMI transfer

protocols are required if

PCI not offered)

• Chest Pain Center

• Peripheral Vascular

Intervention (PVI)

• Perfusion Services

• Full Respiratory Services

• Full Laboratory Services

• Blood Bank (onsite)

• Onsite Cardiac

• nSTEMI patients with

care pathways for non-

invasive strategies

• STEMI with lytic therapy

(if/when indicated)

• Low risk chest pain

• Transfer protocols to a

higher level of care if

needed

• Electrophysiology

• Transcatheter Aortic

Valve Replacement

Rehabilitation Services

(TAVR)

Cardiac Intervention is not

required to achieve Corazon

CPC accreditation.

Corazon Cardiovascular Accreditation Services

Program

Requirements

CPC Accreditation requires:

• Patient selection criteria

and risk stratification

consistent with current

standards

• Collaborative agreement

with a nearby OHS

program (if not also

providing OHS onsite)

• Standards and

Cath/PCI Accreditation

requires:

• Patient selection criteria

and risk stratification

consistent with current

standards

• Collaborative agreement

with an OHS program

within 60 minutes (if not

providing OHS onsite)

OHS Accreditation requires:

• Patient selection criteria

and risk stratification

consistent with current

standards

CV SLoE Accreditation

requires:

• Accreditation of the most

complex cardiovascular

service offered (i.e. OHS

or Cath/PCI)

• Standards and

documentation of training • Accreditation of a total of

and competency of all

key clinical staff

three (3) cardiovascular

services

• Maintain “good standing”

in all accreditations

• Hospital requirements for

credentialing of

documentation of training • Vascular surgery back

and competency of all

key clinical staff

• Hospital requirements for

credentialing of

participating physicians

• Availability of the service

24/7/365

• Emergency care

protocols to ensure rapid

treatment

• Availability of MI Registry

reports or equivalent

data on a quarterly basis

• Outcomes which meet or

exceed the 50^th

up (either onsite or

protocols for immediate

transfer, if indicated)

• Standards and

participating physicians

• Availability of the service

24/7/365

• Emergency care

protocols to ensure rapid

treatment

• Collaborative structure

evidenced by a Heart

Care Team approach

• Availability of STS

Registry reports or

equivalent data on a

quarterly basis

documentation of training

and competency of all

key clinical staff

• Hospital requirements for

credentialing of

participating physicians

• Availability of the service

24/7/365

• Emergency care

protocols to ensure rapid

treatment

• Outcomes which meet or

exceed the 50^th

percentile for key metrics

• Continuous quality

improvement initiative,

including key outcomes

• Adequate policies,

procedures, and

• Collaborative structure

evidenced by a Heart

Care Team approach

• Availability of Cath/PCI

Registry reports or

percentile for key metrics

• Continuous quality

improvement initiative,

including key outcomes

• Adequate policies,

procedures, and

equivalent data on a

quarterly basis

documentation

• Outcomes which meet or

• Appropriateness of

available equipment and

supplies

• Ability to successfully

manage dry-run test

patient scenarios

• Appropriateness of

available equipment and

supplies

exceed the 50^th

percentile for key metrics

• Continuous quality

improvement initiative,

including key outcomes

Corazon Cardiovascular Accreditation Services

• Adequate policies,

procedures, and

• Ability to successfully

manage dry-run test

patient scenarios

documentation

• Appropriateness of

available equipment and

supplies

• Ability to successfully

manage dry-run test

patient scenarios

Case Review

Requirements

• Review of 6 random

charts during the onsite

survey to represent

various chest pain

patient types

• Review of 10 random

charts and direct case

observation (if feasible)

during the onsite survey

• Review of 20 cases by a

physician reviewer for

appropriateness and

documentation

• Review of 10 random

charts and direct case

observation during the

onsite survey

• Review of 20 cases

(CABG and/or valve) by

a physician reviewer for

appropriateness and

documentation

• Completed through

individual accreditations

as applicable

Accreditation

Touchpoints

• Initial planning call to

schedule survey

• Onsite survey and exit

presentation (including

outcome of survey)

• Initial planning call to

schedule survey

• Onsite survey and exit

presentation (including

outcome of survey)

• Initial planning call to

schedule survey

• Onsite survey and exit

presentation (including

outcome of survey)

• All scheduled

touchpoints through each

individual accreditation

• Up to eight (8) hours per

year of consultative

support (participation in

meetings, data analysis,

or other program needs)

• Participation in quality

forum meeting during

onsite survey

• Participation in quality

forum meeting during

onsite survey

• Participation in quality

forum meeting during

onsite survey

• Quarterly calls to review

outcomes data

• Quarterly Accreditation

Client Forum call

• Feedback following

physician case review

• Quarterly calls to review

outcomes data

• Feedback following

physician case review

• Quarterly calls to review

outcomes data

participation (optional)

• Re-accreditation survey

every two (2) years

• Quarterly Accreditation

Client Forum call

participation (optional)

• Re-accreditation survey

every two (2) years

• Quarterly Accreditation

Client Forum call

participation (optional)

• Re-accreditation survey

every two (2) years

Corazon Cardiovascular Accreditation Services

Heart Attack

Systems of

Care

Corazon CPC Accreditation

is typically consistent with a

Level III heart attack/STEMI

referring hospital as

described in the Systems of

Care for ST-Segment-

Elevation Myocardial

Infarction: A Policy

Corazon Cath/PCI

Accreditation is typically

consistent with a Level II

OHS Accreditation is

typically consistent with a

Level I heart attack/STEMI

CV SLoE Accreditation can

apply to a variety of heart

attack center descriptions

depending on the services

accredited within that facility.

Equivalency

heart attack/STEMI receiving receiving hospital as

hospital as described in the

Systems of Care for ST-

Segment-Elevation

described in the Systems of

Care for ST-Segment-

Elevation Myocardial

Infarction: A Policy

Myocardial Infarction: A

Policy Statement from the

American Heart Association

which focuses on timely

reperfusion therapies for

STEMI, NSTEMI, and other

life-threatening, time-

sensitive cardiac

Statement from the

American Heart Association

which focuses on timely

reperfusion therapies for

STEMI, NSTEMI, and other

life-threatening, time-

sensitive cardiac

American Heart Association

which focuses on timely

reperfusion therapies for

STEMI, NSTEMI, and other

life-threatening, time-

sensitive cardiac

emergencies.

Corazon does not require

minimum volumes for

accreditation, unless

required for compliance with

state regulations.

Corazon does not require

minimum volumes for

accreditation, unless

required for compliance with

state regulations.

Corazon does not require

ECMO or LVAD, however

they will be evaluated if

offered by the facility.

Trinity Health Michigan

August 22, 2023

Elizabeth Hertel, Director

Department of Health and Human Services

Sarah Lyon-Callo, Senior Deputy Director

Public Health Administration

Jay Fiedler, State Bureau Administrator

Eileen Worden, Systems of Care Manager

Bureau of Emergency Preparedness, EMS, and Systems of Care

333 S. Grand Avenue

P.O. Box 30195

Lansing, MI 48909

Subject: Statewide STEMI System R 330.201 – R 330.230 (Pending Rule Set 2022-61 HS)

Department Representatives,

I am writing on behalf of Trinity Health Michigan regarding the pending administrative rule

set 2022-61 HS regarding establishing a statewide STEMI system of care. Our

organization strongly supports the need for this type of system of care for the health and

wellbeing of Michiganders across our state. We are already committed to providing

excellent patient care for STEMI and suspected STEMI patients and support a system

which will provide greater certainty for our first responders and communities related to the

care they receive.

In fact, it is our existing commitment to STEMI and other cardiovascular care that is the

reason for this letter. Trinity Health Michigan has maintained accreditation for

interventional cardiology services through Corazon, Inc. for several years. Corazon is

recognized by the Michigan Department of Health and Human Services under the existing

CON Review Standards for Cardiac Catheterization Services. As part of this ongoing

accreditation, Corazon evaluates our STEMI protocols and ability to manage these

patients effectively. Furthermore, Corazon requires quarterly reporting of outcomes data

to ensure ongoing improvement efforts related to key metrics, including timely treatment

of STEMI patients, whether the patient presents to our organization or is a candidate for

transfer.

In reviewing the proposed rule language, accreditation by a “department-approved

nationally recognized professional certifying and accrediting organization” is required.

While Corazon has been approved by the Department previously for Cardiac

Catheterization Services, Corazon is not named in the proposed statewide STEMI system

1600 S. Canton Center Road, Suite 301, Canton, MI 48188

Trinity Health Michigan

rule. To avoid confusion, and based on our organization’s experience with Corazon and

the standards they require of our current cardiovascular program, Corazon should be

named under the proposed administrative rule. Otherwise, this could cause confusion

within our community, with the Emergency Medical Services providers in our region, and

even with the Department as to the good standing of our program.

In further discussion with Corazon, we understand they have submitted information to the

Bureau of Emergency Preparedness, EMS, and Systems of Care to attest to their status

as an equivalent accreditation organization to those named in the proposed rule

language. Unless the Department or the Bureau has found gaps in the standards Corazon

has proposed, we request the proposed rule language be amended as follows: